EFFICACY OF HARIDRADI GRANULES IN THE MANAGEMENT OF STANYAKSHAYA: AN EXPLORATORY STUDY
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- To find out the efficacy of Haridradi Granules in the management of Stanyakshaya.
研究概览
简要总结
Stanya is Jeevana Amshaas it is the chief source of nutrition and diet for new born baby .. Acharya Charaka has quoted that the new born should be put to breast from the very first day of birth. Stanya, as it is formed by Prasada of Ahara Rasa it contains best of all nutrients needed for the child.Stanyakshaya is one of the Vikruti of Stanya. In Stanyakshaya there is Kshaya due to Dhatukshayaand Dushti. Ayurveda Acharyasconsider Stanyakshya to be a serious issue, and they have thoroughly described the condition, including the causative factors and management. Main causes are Langhana, Rukshannapana Sevana, Karshana (emaciation), Atyapatarpan (excessive fasting), Shodhana Atiyoga, Krodha, Bhaya, Shoka, Kama and Avatsalyatwa, etc. OBJECTIVES****PRIMARY OBJECTIVE - To find out the efficacy of Haridradi Granules in the management of Stanyakshaya.
SECONDARY OBJECTIVE –
To find out the effective weight gain in infants by improving quantity of breast milk.
METHODOLOGY
| Study | |
| type |
Exploratory
|Primary Purpose
Efficacy
|Masking
Open labelled
|Timing
Prospective
|Sample size
47
|Primary Outcome
Changes in milk production rate from baseline to endline (60th day)
|Secondary Outcome
Changes in PIM (Perceived insufficient milk) score.
PARAMETER FOR ASSESSMENT OF STUDY OUTCOME –
During the trial and follow up study the patients will be assessed on the basis of parameters
SUBJECTIVE PARAMETERS :
The parental PIM score will be evaluate using the validated McCarter-Spaulding and Kearner Perceived Insufficient Milk Questionnaire.
OBJECTIVE PARAMETERS:
1. The Human milk production rate will be calculated at baseline and at endline using validated milk expression protocol.[i]
2. Weight of the baby will be calculated at baseline, during treatment and at 60th day.
[i] Roznowski DM, Wagner EA, Riddle SW, Nommsen-Rivers LA. Validity of a 3-hour breast milk expression protocol in estimating current maternal milk production capacity and infant breast milk intake in exclusively breastfeeding dyads. Breastfeed Med. 2020;15:630-638. doi: 10.1089/bfm.2019.0182
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age group between 20 to 35 years irrespective to religion, socio-economic status and food habits Patients either of Primigravida or Multigravida will be selected.
- •Patients after delivery from 5th day to 6 months.
- •Patients with previous history of lactation deficiency.
- •Breast feeding frequency less than 4-5 times/day.
- •Patient having baby of less than 6 month of age, partially or totally on top feed.
- •Patient’s delivery should be at full term.
排除标准
- •Patient with congenital anomalies of breast (absence of nipple or the breast tissue).
- •Patient with breast atrophy, mastitis, breast abscess.
- •Patient with known case of immune compromised disease like AIDS, Cancer.
- •Patients with reactive viral markers.
- •Patient with known case of systemic disease like Diabetes mellitus.
- •Patient’s baby with congenital anomalies (cleft lip, cleft palate), birth trauma, premature birth.
- •Patient who is taking anti prolactin drug (bromocriptine, cabergoline) which suppress lactation.
- •Patient who is taking anti emetic drug (metoclopramide, domperidone) or antipsychotic drug (sulpiride) which increase lactation.
结局指标
主要结局
To find out the efficacy of Haridradi Granules in the management of Stanyakshaya.
时间窗: 2 months
次要结局
- To find out the effective weight gain in infants by improving quantity of breast milk.(2 months)
研究者
Dr Rukhsar
All India Institute of Ayurveda